U.S. FDA Approves NEXAVAR® (sorafenib) for the Treatment of Patients with Locally Recurrent or Metastatic, Progressive, Differentiated Thyroid Carcinoma Refractory to Radioactive Iodine Treatment
First and only FDA-approved treatment option for patients with this type of thyroid cancer

WHIPPANY, N.J., THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Nov. 22, 2013 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for the oral multi-kinase inhibitor NEXAVAR® (sorafenib) tablets for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment. NEXAVAR was approved following a priority review by the FDA, a designation reserved for drugs that may offer a significant improvement in treatment over existing options.

"Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment is difficult to treat," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "NEXAVAR is the first and only FDA-approved therapy for this type of thyroid cancer and is a positive development for patients who previously had limited treatment options."

"We are pleased to be able to offer NEXAVAR as a treatment option for patients with thyroid cancer who are no longer responding to standard therapy," said Pablo J. Cagnoni, M.D., President, Onyx Pharmaceuticals, Inc. "We are committed to making this treatment available to physicians and their patients as quickly as possible."

"An unmet medical need exists for this type of thyroid cancer, underscoring the need for new therapies," said Gary Bloom, Executive Director of ThyCa: Thyroid Cancer Survivors' Association, Inc. "We are excited that an FDA-approved treatment is now available to patients coping with this challenging type of thyroid cancer."

DECISION Trial The FDA approval is based on the results of the DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial, an international, multicenter, placebo-controlled study.

"The DECISION trial results show sorafenib's ability to extend progression-free survival compared to placebo in patients with this type of advanced thyroid cancer," said Marcia Brose, MD, PhD, assistant professor in the Department of Otorhinolarlyngology: Head and Neck Surgery and the division of Hematology/Oncology in the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. "Physicians now have an approved treatment option that may help improve care in this patient population."

A total of 417 patients with locally recurrent or metastatic, progressive differentiated thyroid carcinoma refractory to radioactive iodine treatment were randomized to receive 400 mg of oral sorafenib twice daily (207 patients) or matching placebo (210 patients). Metastases were present in 96% of the patients: lungs in 86%, lymph nodes in 51%, and bone in 27%.

About Thyroid CancerThyroid cancer has become one of the fastest-increasing cancers in recent years and is the sixth most common cancer in women.1,2 There are more than 213,000 new cases of thyroid cancer annually and approximately 35,000 people die from thyroid cancer worldwide each year.3

Papillary, follicular and Hurthle cell types of thyroid cancer are classified as "differentiated thyroid cancer" and account for approximately 94 percent of all thyroid cancers.4 While the majority of differentiated thyroid cancers are treatable, locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment is more difficult to treat.4,5

About NEXAVAR® (sorafenib) TabletsNEXAVAR is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. NEXAVAR is thought to inhibit both the tumor cell and tumor vasculature. In in vitro studies, NEXAVAR has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

NEXAVAR is currently approved in more than 100 countries. NEXAVAR is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.

NEXAVAR is co-developed by Onyx and Bayer, except in Japan where Bayer manages all development. The companies co-promote NEXAVAR in the U.S. Outside of the U.S. Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally, excluding Japan.

Onyx and Bayer offer a patient assistance program REACH (Resources for Expert Assistance and Care Helpline) for patients who are not able to pay for NEXAVAR. The companies also provide financial support to co-pay foundations. For more information, visit www.NEXAVAR-us.com.

Important Safety Considerations For NEXAVAR® (sorafenib) TabletsNEXAVAR in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.

Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter, and treat, if required.

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of NEXAVAR should be considered. NEXAVAR should be discontinued if Stevens-Johnson syndrome or toxic epidermal necrolysis are suspected as these may be life-threatening.

Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking NEXAVAR. Discontinue NEXAVAR in the event of a gastrointestinal perforation.

Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time (PT), International Normalized Ratio (INR), or clinical bleeding episodes.

Temporary interruption of NEXAVAR therapy is recommended in patients undergoing major surgical procedures.

NEXAVAR, in combination with gemcitabine/cisplatin, is not recommended in patients with squamous cell lung cancer. The safety and effectiveness of NEXAVAR has not been established in patients with non-small cell lung cancer.

NEXAVAR can prolong the QT/QTc interval and increase the risk for ventricular arrhythmias. Avoid use in patients with congenital long QT syndrome and monitor patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Interrupt NEXAVAR if QTc interval is greater than 500 milliseconds or for an increase from baseline of 60 milliseconds or greater.

Drug-induced hepatitis with NEXAVAR may result in hepatic failure and death. Liver function tests should be monitored regularly and in cases of increased transaminases without alternative explanation NEXAVAR should be discontinued.

NEXAVAR may cause fetal harm when administered to a pregnant woman. Women of child-bearing potential should be advised to avoid becoming pregnant while on NEXAVAR and female patients should also be advised against breastfeeding while receiving NEXAVAR.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with NEXAVAR.

Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of sorafenib. NEXAVAR exposure decreases when co-administered with oral neomycin. Effects of other antibiotics on NEXAVAR pharmacokinetics have not been studied.

For information about NEXAVAR including U.S. NEXAVAR prescribing information, visit www.NEXAVAR-us.com or call 1.866.NEXAVAR (1.866.639.2827).

About Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

About AmgenAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

About Onyx Pharmaceuticals, Inc.Based in South San Francisco, California, Onyx Pharmaceuticals, Inc., an Amgen subsidiary, is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.com. Onyx Pharmaceuticals is on Twitter. Sign up to follow our Twitter feed @OnyxPharm at http://twitter.com/OnyxPharm.

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NEXAVAR® is a registered trademark of Bayer AG.

*Editor's note: Dr. Brose has received consulting fees and honoraria from Bayer HealthCare and Onyx Pharmaceuticals.